Value of ultrasound-guided vacuum-assisted excision in the treatment of non-malignant breast nodules diagnosed as BI-RADS 4A or higher by ultrasound

Introduction

According to the American College of Radiology’s Breast Imaging Reporting and Data System (BI-RADS), lesions categorized as 4A to 4C exhibit a progressively increasing risk of malignancy, ranging from 2% to 95% (1). Given this broad spectrum, obtaining an accurate pathological diagnosis is crucial for guiding clinical management. While core needle biopsy (CNB) remains a standard diagnostic tool, its limitations—including sampling variability and lesion heterogeneity—can lead to underestimation rates and false-negative results, particularly in high-risk lesions such as atypical ductal hyperplasia (ADH) and ductal carcinoma in situ (DCIS) (2,3). In contrast, vacuum-assisted biopsy (VAB) allows for larger tissue sampling, providing more comprehensive pathological assessment, improving diagnostic accuracy, and reducing the need for repeat biopsies (4). Building upon this technology, ultrasound-guided vacuum-assisted excision (VAE) has emerged as a diagnostic and therapeutic breakthrough. Compared with CNB, VAE achieves superior diagnostic efficacy through more extensive tissue acquisition, while offering minimally invasive advantages over traditional open surgery.

VAE is recommended for the management of breast lesions of uncertain malignant potential (5). Given that most BI-RADS 4A lesions are benign, VAE is clinically utilized for their management. VAE may also be selectively employed for a limited number of small-sized BI-RADS 4B and 4C lesions when aligned with patient preference. However, the role of VAE in high-risk lesions remains controversial. Although surgical excision (SE) has been the traditional standard, VAE has gained traction as a potential alternative in select cases. For suspected high-risk lesions, biopsy remains mandatory (6,7). If pathology confirms malignancy or reveals imaging-histology discordance, surgical intervention is warranted. Conversely, confirmed benign lesions may be managed with observation and follow-up. Despite growing interest in VAE for benign and high-risk lesions, large-scale clinical studies validating its long-term efficacy for BI-RADS 4A and higher non-malignant nodules remain limited (8,9).

This retrospective study aimed to evaluate the therapeutic effectiveness of ultrasound-guided VAE in treating BI-RADS 4A and higher non-malignant breast nodules. By analyzing postoperative recurrence rates, malignant transformation rates, and associated risk factors, we seek to provide evidence-based insights to optimize clinical decision-making. We present this article in accordance with the STROBE reporting checklist (available at https://gs.amegroups.com/article/view/10.21037/gs-2025-aw-476/rc).

Methods

Patients information

This study retrospectively collected data from 592 patients who underwent ultrasound-guided VAE for breast nodules classified as BI-RADS 4A or higher by ultrasound at Peking University Third Hospital between January 2014 and December 2022. Among these, 226 patients were excluded due to loss to follow-up, and an additional 68 patients were excluded because their follow-up duration was less than 12 months. Thirty-one patients were excluded because of malignant pathology results following VAE. Five patients were excluded due to incomplete ultrasound data. Ultimately, 262 patients were included in the study. Inclusion Criteria: Ultrasound-detected breast nodules classified as BI-RADS category 4A or higher. Patients who underwent a complete VAE procedure. Availability of comprehensive clinical records and complete imaging data. Exclusion criteria: pathological confirmation of malignancy following VAE procedure. Previous surgical intervention for breast nodules. Cases of recurrent breast nodules. Patients lost to follow-up or with incomplete clinical/imaging documentation. In our center, clinicians typically recommend ultrasound-guided VAE for patients with BI-RADS 4A and smaller-sized BI-RADS 4B and 4C lesions because patients prefer VAE, as this technique serves both diagnostic and therapeutic purposes. If the pathological results are benign, patients are advised to return for clinical and ultrasound follow-up. If malignancy is detected, surgical intervention is recommended.

The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. This research was approved by the Medical Ethics Committee of Peking University Third Hospital (No. 2025-572-02). Given that this was a retrospective study utilizing anonymized data, the requirement for informed consent was waived.

VAE technology

Preoperative detailed breast ultrasound examination is performed. A sonographer with at least five years of experience in breast ultrasound uses a Philips iU22 L12-5 linear array transducer (Philips Healthcare, Bothell, WA, USA), L9-4 MHz (RS80A, Samsung, Hongcheon-gun, Gangwon-do, South Korea), L12-5MHz (EPIQ 7, Philips), L12-5 MHz (LOGIQ E9, GE, Washington, DC, USA) to scan and determine the location and size of the lesion. The insertion point and the long axis of the lesion are marked on the skin surface with a marker pen. Subsequently, the surgeon determines the surgical approach based on the location and size of the lesion, as well as aesthetic considerations.

Local anesthesia is administered during the procedure, with 10 mL of 1% lidocaine injected around the mass and along the anticipated needle path. Adrenaline may be added at a 1:100,000 ratio if necessary. After achieving adequate anesthesia, one of the surgeons makes a 3–4 mm skin incision under ultrasound guidance and precisely positions the needle beneath the lesion using an 8-gauge vacuum-assisted needle (Mammotome breast biopsy system, Devicor Medical Products, Inc., Cincinnati, OH, USA). Depending on surgical requirements, the probe and needle are rotated to obtain tissue from different angles until ultrasound imaging confirms complete removal of the lesion. To ensure thorough excision, one sample is taken from the surrounding breast tissue at the 12, 3, 6, and 9 o’clock positions. The definitions are established on the human cross-section: The 12 o’clock position corresponds to the ventral side of the body, the 3 o’clock position to the patient’s left side, the 6 o’clock position to the dorsal side, and the 9 o’clock position to the patient’s right side. The excised tissue is automatically aspirated into the sampling chamber via negative pressure and transferred to a collection basket.

Postoperatively, compression is applied for 10 to 15 minutes to ensure adequate hemostasis, and an ultrasound is performed to confirm the absence of residual lesions or significant hematoma. Finally, an elastic bandage is applied for 48 hours, and analgesic medications are provided as needed based on patient requirements.

Patients follow-up

It is recommended that the patient undergo clinical and ultrasound follow-up 6 months postoperatively. For the first 2 years, follow-up examinations should be conducted every 6 months to assess the previously excised site and adjacent areas for any suspicious lesions. If no suspicious lesions are detected during the follow-up period, the patient may resume routine screening. Recurrent lesions were strictly defined as those demonstrating: Histological concordance with the primary lesion, and spatial localization within 2–3 cm of the original excision site. Malignant transformation refers to the occurrence of a malignant lesion within 2–3 cm of the previous excision site, confirmed by pathological examination.

Statistical analysis

Statistical analysis was performed using SPSS 26.0 software (IBM Corporation, New York, USA). Continuous variables were described using mean ± standard deviation, while categorical variables were expressed as proportions. For normally distributed continuous variables, the t-test was used, and the chi-square test was applied for categorical variables. A P value of less than 0.05 (two-tailed significance test) was considered statistically significant.

Results

The basic patient information is shown in Table 1. The average age of all patients was 42.58 years. Among them, 259 cases (98.9%) had lesions in the unilateral breast, and 3 cases (1.1%) in bilateral breasts. According to the BI-RADS classification, 246 cases (93.9%) were categorized as 4A, 14 cases (5.3%) as 4B, and 2 cases (0.8%) as 4C. Among all patients, 165 cases (63.0%) had a maximum lesion diameter of ≥1 cm, while 97 cases (37.0%) had a maximum lesion diameter of <1 cm. The distance from the nodule to the nipple was 2.25±1.58 cm, and the distance to the skin was 0.83±0.36 cm. The follow-up period ranged from 12 to 122 months, with an average of 45.73 months.

Among all patients, 91 cases (34.7%) were diagnosed with hyperplastic lesions, 54 cases (20.6%) with intraductal papilloma, 4 cases (1.5%) with benign phyllodes tumors, 78 cases (29.8%) with fibroadenoma, 26 cases (9.9%) with breast adenosis, 8 cases (3.1%) with inflammatory lesions, and 1 case (0.4%) with hamartoma, as shown in Table 2. Among the 262 patients, 10 cases experienced recurrence during follow-up. Of these recurrent cases, 7 (70%) were intraductal papillary tumors (Figure 1), and 3 (30%) were benign phyllodes tumors, resulting in a recurrence rate of 3.8%. Additionally, 1 case underwent malignant transformation during follow-up, with a malignant transformation rate of 0.4%. The pathological result of the malignant transformation case was consistent with breast adenosis. The overall recurrence and malignant transformation rate were 4.2% (11/262). Detailed information on the recurrence and malignant transformation cases is presented in Table 3.

Figure 1 Ultrasound images of a breast nodule in a patient with recurrence. (A,B) The initial breast nodule detected in 2016. The nodule was located at the 2 o’clock position of the left breast, and measured 1.2 cm × 0.5 cm. It was classified as BI-RADS 4A. The patient underwent VAE, and the pathological result was intraductal papillary tumor. (C,D) A recurrent left breast nodule measuring 1.5 cm × 0.5 cm in diameter was detected during follow-up in 2021. It was classified as BI-RADS 4A. The patient underwent a second VAE, and the pathological result remained consistent with intraductal papillary tumor. BI-RADS, Breast Imaging Reporting and Data System; VAE, vacuum-assisted excision.

We stratified patients with pathological diagnoses of intraductal papillary tumors, phyllodes tumors, and mammary adenosis into groups based on the presence or absence of recurrence or malignant transformation. No significant differences were observed between the non-recurrence/non-malignant transformation group and the recurrence/malignant transformation group in terms of age, distance from the nipple, lesion size or BI-RADS classification. There was a statistically significant difference in laterality between the two groups (Table 4).

Figure 2 shows the malignant transformation case. The patient underwent VAE surgery in April 2017, and the pathological result after VAE was breast adenosis. The patient underwent follow-up observation, and regular breast ultrasound examinations showed no significant abnormalities. In May 2019, a left breast nodule was again detected, measuring about 1.5 cm × 0.7 cm, and revealed a BI-RADS 4B lesion. The patient and the medical team mutually decided to proceed with SE. Intraoperative frozen section pathology indicated breast cancer, and after consultation with the surgeon and the patient’s family, a modified radical mastectomy combined with sentinel lymph node biopsy was performed. The final postoperative pathology revealed high-grade DCIS (grade 3) with comedo necrosis, and multiple foci of invasion were observed. Sentinel lymph nodes showed no evidence of metastasis (0/2). The patient received chemotherapy with the TC regimen on June 12, 2019, and the treatment was deemed to be effective.

Figure 2 Ultrasound images of a breast nodule in a patient with malignant transformation. (A,B) A left breast nodule discovered in April 2017, measuring approximately 0.8 cm × 0.5 cm. It was identified as a BI-RADS 4A lesion. (C,D) The ultrasound findings during a follow-up examination 25 months after the VAE procedure. A left breast nodule was again detected measuring about 1.5 cm × 0.7 cm. It was identified as a BI-RADS 4B lesion. BI-RADS, Breast Imaging Reporting and Data System; VAE, vacuum-assisted excision.

Discussion

This study aimed to evaluate the effectiveness of VAE in treating BI-RADS 4A or higher non-malignant breast nodules diagnosed by ultrasound, with a particular focus on recurrence and malignant transformation rates. Our findings demonstrate that VAE is a safe and effective minimally invasive technique for the diagnosis and treatment of benign and high-risk breast lesions, with a low overall recurrence rate of 3.8% and a malignant transformation rate of 0.4%. These results are consistent with previous studies that have highlighted the diagnostic and therapeutic benefits of VAE for benign breast lesions (10). In our study, the recurrence rate of 3.8% is comparable to rates reported in other studies. Bennett et al. (11) reported a recurrence rate of approximately 4% in a multicenter study evaluating VAE for benign breast lesions. Similarly, Mathew et al. (10) found a recurrence rate of 3.5% in their cohort of patients undergoing VAE for clinically benign breast lesions. Our results further support the notion that VAE is an effective treatment modality for reducing the risk of recurrence in patients with BI-RADS 4A or higher breast nodules diagnosed by ultrasound. Hahn et al. (12) emphasized the importance of VAE as a minimally invasive technique that not only provides accurate pathological diagnosis but also allows for complete lesion removal, thereby reducing the need for further surgical intervention. Our findings further reinforce this perspective, as the majority of patients in our cohort did not require additional surgery following VAE, and the recurrence and malignant transformation rates were low. However, our study also highlights the importance of careful patient selection and biennial follow-up (13,14). While VAE is effective for most benign lesions, certain pathological subtypes, such as intraductal papilloma and benign phyllodes tumors, may require closer monitoring due to their higher recurrence rates. Additionally, the occurrence of malignant transformation, albeit rare, underscores the need for ongoing surveillance in patients with specific benign lesions, such as breast adenosis.

CNB represents a crucial biopsy technique; however, it demonstrates significant underestimation and false-negative rates for certain benign breast lesions as well as high-risk lesions, including ADH and DCIS (3). Current evidence reveals substantial variability in malignant upgrade rates (0–29%) following SE of CNB-diagnosed benign papillary lesions (15). Park et al.’s retrospective analysis of 179 female patients over ten years reported a 10.6% upgrade rate (16), while Polat et al.’s larger cohort study (n=332) identified upgrade to DCIS in 2.1% (7 cases) and to high-risk lesions in 12.3% (41 cases) (17). Notably, age significantly influences upgrade risk, with patients ≥50 years showing higher upgrade rates (16%) versus younger patients (2%) (18). Lin et al. specifically noted that intraductal papillomas with ADH carry particularly high upgrade risks (27%) (2).

With technological advancements in minimally invasive procedures, ultrasound-guided VAE has emerged as a pivotal diagnostic and therapeutic modality for benign breast nodules (10-12). Originally developed for breast lesion biopsy, this technique has expanded to include the treatment of benign breast tumors. VAB demonstrates superior diagnostic performance compared to CNB by obtaining larger tissue samples. Fahrbach’s meta-analysis revealed 97.3% histopathologic concordance for VAB versus 93.5% for CNB (19). Comparative studies show CNB’s false-positive/negative rates reach 2.5%, while VAB maintains 0% false-positives, with CNB particularly underperforming for borderline lesions like ADH/DCIS (4). Suh et al. documented significantly lower DCIS underestimation with VAB (16.1%) versus CNB (47.8%) (P<0.001) (20). The phase III RCT (NCT04612439) confirmed Elite 10-G VAB’s superiority over 14-G CNB, showing lower overall malignancy underestimation (21.4% vs. 30.9%, P=0.04) and better accuracy for calcified lesions (93.2% vs. 88.3%, P=0.02) (21). For non-mass lesions, multiple studies confirm VAB’s diagnostic superiority (4,22).

Currently, VAE has been widely applied in the treatment of benign breast nodules and selected high-risk lesions, serving as an important alternative to open SE. Multiple clinical studies have demonstrated the significant advantages of VAE: it achieves a complete excision rate exceeding 94%, maintains a low complication rate of only 5%, and provides diagnostic accuracy comparable to conventional SE. The study by Giannotti et al. (23) specifically highlighted that in the treatment of high-risk breast lesions, the malignant upgrade rate following VAE was 8.6%, confirming not only the efficacy of this technique but also its ability to significantly reduce the need for SE. Further supporting this, van de Voort’s team (24) utilized a predictive model to demonstrate that employing VAE for both benign and high-risk breast lesions leads to a substantial reduction in hospitalization costs. This economic advantage was validated by a prospective, single-blind, randomized controlled trial conducted in Sweden (25), which showed that VAE is markedly superior to SE in terms of healthcare costs while exhibiting no statistically significant difference in complication rates.

However, the use of VAE for treating high-risk lesions remains controversial. High-risk breast lesions represent a group of highly heterogeneous diseases, and the formulation of clinical diagnosis and treatment strategies for them poses certain challenges. Traditionally, surgical resection has been the main treatment approach for this category of lesions. However, in recent years, VAE has gradually emerged as an alternative treatment option for some cases. Currently, multiple international guidelines offer differentiated recommendations regarding the application of VAE in high-risk lesions. The Second and Third International Consensus Conferences on Breast Lesions of Uncertain Malignant Potential (2018) indicated that, except for ADH and phyllodes tumors, which still require surgical resection, VAE is recommended as the preferred treatment for other high-risk lesions with a diameter of less than 25 mm (6,26). In the same year, the UK NHS Breast Screening Multidisciplinary Working Group guidelines suggested limiting the indication of VAE to high-risk lesions smaller than 20 mm (27). In terms of clinical research, several retrospective studies have provided evidence-based support for the application of VAE. van de Voort et al.’s study demonstrated that VAE can replace traditional surgery in specific high-risk breast lesion patients, with postoperative recurrence rates (2.0%) and re-resection rates (3.9%) at relatively low levels. However, the researchers suggested that further validation through prospective studies is still needed (8). Clinical data reported by Italian scholars showed that the malignant upgrade rate of high-risk lesions after VAE was 7.5% (9), which was consistent with the 8.6% upgrade rate reported in other studies (23), further confirming the relatively low rate of malignant transformation after VAE. Another Italian study indicated that ultrasound-guided VAE is the best tool for therapeutic resection of selected high-risk lesions, offering higher success rates, better patient compliance, and significant cost savings compared to surgery (28). This technique has the potential to reduce unnecessary surgeries and medical expenses. Based on the existing guideline recommendations and clinical research evidence, we believe that VAE shows promising application prospects and clinical value in the treatment of specific high-risk breast lesions. Its minimally invasive advantages and acceptable risk of malignant upgrade make it a potential preferred treatment option for some patients.

Our study identified that intraductal papilloma and benign phyllodes tumors were the most common pathological subtypes associated with recurrence, which is consistent with previous studies (29,30). Specifically, 70% of recurrent cases were intraductal papilloma, and 30% were benign phyllodes tumors. This finding is consistent with previous studies that have reported a higher recurrence rate for intraductal papilloma following VAE (31). Intraductal papilloma typically exhibits multifocal growth, primarily located within the ducts, and often has a small lesion volume, making it difficult to distinguish from the surrounding normal glandular tissue. The high recurrence rate of phyllodes tumors, although based on a small sample size in our study, also warrants attention, as these tumors are known for their potential to recur and, in some cases, progress to malignancy (32). Phyllodes tumors are prone to aggressive growth, leading to indistinct margins. Insufficient excision margins during VAE may result in the residual presence of small tumor foci, subsequently leading to postoperative recurrence. Malignant phyllodes tumors exhibit rapid growth and possess strong infiltrative and metastatic capabilities, making complete tumor resection particularly challenging.

The malignant transformation rate in our study was 0.4%, which is relatively low but not negligible. The case of malignant transformation occurred in a patient initially diagnosed with breast adenosis, suggesting that certain benign lesions may have a higher potential for malignant transformation over time. This finding aligns with previous literature, which has indicated that while most benign breast lesions remain stable, a small subset may progress to malignancy, particularly in cases of sclerosing adenosis or other high-risk lesions. Therefore, long-term follow-up is essential for patients undergoing VAE, especially those with specific pathological subtypes that may carry a higher risk of malignant transformation. In this study, the pathological result of the malignant case revealed high-grade DCIS. The sentinel lymph nodes examined showed no evidence of metastatic carcinoma. This indicates that follow-up after VAE can facilitate the early detection of malignant transformation, which is beneficial for patients to receive timely treatment.

This study has several limitations. The exclusion of malignant cases limits the generalizability of our findings to preoperative decision-making. These data contribute to informing preoperative selection. We only emphasize the necessity of long-term postoperative follow-up; however, they present certain limitations in providing detailed surveillance protocols. Our research is a retrospective analysis, which may introduce selection bias. In addition, the follow-up duration varied among patients, with some having a relatively short follow-up period, which may have affected the detection of late recurrences or malignant transformations. What is more, the sample size for certain pathological subtypes, such as phyllodes tumors, was small, limiting the generalizability of our findings for these specific lesions. Finally, this study primarily focuses on BIRADS 4A lesions. A small number of patients with relatively smaller-sized BIRADS 4B and 4C lesions opted for VAE based on personal preference; however, the number of these cases is very limited, and their generalizability is constrained.

Conclusions

In conclusion, our study demonstrates that ultrasound-guided VAE is an effective and minimally invasive treatment option for BI-RADS 4A or higher non-malignant breast nodules diagnosed by ultrasound, with low recurrence and malignant transformation rates. However, certain pathological subtypes, such as intraductal papilloma and benign phyllodes tumor, may require closer monitoring due to their higher recurrence potential. Long-term follow-up is essential, particularly for patients with lesions that have a higher risk of malignant transformation. These findings provide additional evidence to support the use of VAE in clinical practice, while also highlighting the importance of individualized patient management and surveillance.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://gs.amegroups.com/article/view/10.21037/gs-2025-aw-476/rc

Data Sharing Statement: Available at https://gs.amegroups.com/article/view/10.21037/gs-2025-aw-476/dss

Peer Review File: Available at https://gs.amegroups.com/article/view/10.21037/gs-2025-aw-476/prf

Funding: This study was funded by the 2023 Haidian Innovation and Transformation Special Project of Peking University Third Hospital (No. HDCXZHKC2023209).

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://gs.amegroups.com/article/view/10.21037/gs-2025-aw-476/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. This research was approved by the Medical Ethics Committee of Peking University Third Hospital (No. 2025-572-02). Given that this was a retrospective study utilizing anonymized data, the requirement for informed consent was waived.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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